MaxBlend Lite, Low Flow, 30LPM

GUDID 00853061006791

MAXTEC, LLC

Oxygen/air breathing gas mixer, hospital
Primary Device ID00853061006791
NIH Device Record Key2b176b9d-45d1-45c9-bc94-16148ef96b75
Commercial Distribution StatusIn Commercial Distribution
Brand NameMaxBlend Lite, Low Flow, 30LPM
Version Model NumberR229P03-003
Company DUNS169911828
Company NameMAXTEC, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100853061006791 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZRMixer, Breathing Gases, Anesthesia Inhalation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-01-15
Device Publish Date2018-01-02

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